N-Nitroso N-Desmethyl Clarithromycin: All You Need To Know

You may not think of the science behind antibiotics when taking them, but they’re extremely complex. After all, antibiotics are prescribed to deal with infections so you can feel better. There’s one notion out there, however, that speaks to so much more. N-Nitroso N-Desmethyl Clarithromycin. This antibiotic has a nitrosamine impurity that is able to form within Clarithromycin. As with many things, regulatory agencies are on alert, as some nitrosamines are associated with a plethora of health issues.

But what does this mean for you? Should you be concerned? Let's simplify it for you.

What Are Nitrosamines And Why Are They So Important?

Nitrosamines stem from a variety of sources, including smoke from cigarettes and drinking water. These compounds are found everywhere – in processed foods and even in your water bottle. Some compounds are harmless, whereas others pose serious risks when exposed to for long periods of time. This risk elevates the need for government bodies like the FDA (Food and Drug Administration) and EMA (European Medicines Agency) to formulate stricter guidelines when it comes to drugs.

In recent years, a plethora of previously manufactured drugs with nitrosamine impurities have been observed, leading to recalls and stricter manufacturing regulations.

Clarithromycin's invention caused N-Nitroso N-Desmethyl Clarithromycin’s structure as an impurity, and drug manufacturers are scrutinizing its formation more closely.

Why Does N-Nitroso N-Desmethyl Clarithromycin Come About?

It’s not like it is formed out of thin air. Unlike its other forms, this one can originate from the storage conditions of the drug or even the manufacturing process. Factors like temperature and moisture can interact with other reagents to yield N-Nitroso N-Desmethyl Clarithromycin.

Therefore, pharmaceutical companies need to have rigorous measures in place during production, post-processing, and storage to monitor these impurities and avoid any risks. Their products are constantly checked for even the slightest trace that would be unacceptable under health regulations.

Is There a Need For Concern When Taking Clarithromycin?

Don't panic if you are on treatment with prescribed clarithromycin. Monitoring medicines for impurities, such as nitrosamines, allows for greater control. Drugs are made compliant to test, identify, and reduce any harm their product could cause. In light of steady market regulations, if any product is found extensively exceeding the acceptable limit, it is easily disposed of.

Even so, if you have concerns about your prescribed medication, it is best to contact a healthcare professional. Pharmacists and doctors have easy access to updated recommendations and are in the best position to address any worries you may have.

Global Leaders in Reference Materials Support

Chemicea is here to take the pharmaceutical industry one step further. An officially certified company with and GMP certification, Chemicea’s main focus is on manufacturing high-quality pharmaceutical reference standards to help purify and secure the safety of products by different manufacturers.

Proven with trust by 500+ customers in more than 35 countries, Chemicea is recognized all around the world for its competency, consistency, and quality maintained through advanced machinery. Our 3,000-square-foot pharmaceutical research and development center is built for compliance with regulations during the process of creating new pharmaceutical materials.

Chemicea is the most reliable company for high-quality pharmaceutical reference materials, reference standards, impurity profiling, and metabolite studies.

Contact Chemicea for any pharmaceutical reference materials and receive superlative services.